Label: GNP WITCH HAZEL- witch hazel liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Witch Hazel

  • Purpose

    Astringent

  • Indications

    For relief of minor skin Irritations due to

    minor cuts

    minor scraps

    insect bites

  • Warnings

    For external use only

    avoid contact with eyes

    If contact occurs rinse thoroughly with water.

  • When using this product stop using and contact a doctor if

    condition persists or gets worse

    symptoms do not improve within 7 days

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    In case of eye contact flush eyes with running water for 15 minutes.

  • Directions

    Apply liberally to the afflicted area as often as necessary

  • Inactive ingredients

    Alcohol 14% and purified water.

  • Principal Display Panel

    NDC 46122-335-43
    Witch Hazel
    (Hamamelis Water)
    Distilled Extract
    A
    lcohol 14% by volume
    16 fl oz (1 pt) 473 mL

    Principal Display Panel
NDC 46122-335-43
Witch Hazel
(Hamamelis Water)
Distilled Extract
Alcohol 14% by volume
16 fl oz (1 pt) 473 mL

  • INGREDIENTS AND APPEARANCE
    GNP WITCH HAZEL 
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-335
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL855 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-335-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/2016
    Labeler - Amerisource Bergen (007914906)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(46122-335) , manufacture(46122-335) , pack(46122-335) , label(46122-335)